FDA Registration
Active
🇺🇸 United States
MIRUS, LLC
Reg #: 3014655115
·
FEI: 3014655115
·
Expires 2026
Products
15
Proprietary Names
25
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- MIRUS, LLC
- Registration Number
- 3014655115
- FEI Number
- 3014655115
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1755 W Oak Parkway, Suite 100
- City
- Marietta
- State
- GA
- ZIP
- 30062
- Country
- US
Regulatory Submissions
- 510(k) Number
- K252733
Owner / Operator
- Firm Name
- MiRus, LLC
- Operator Number
- 10059692
- Address
- 1755 West Oak Parkway, Suite 100
- City
- Marietta
- State
- GA
- Postal Code
- 30062
- Country
- US
- Correspondent
- Jordan Bauman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bone Wedge | PLF | Class 2 | Orthopedic | No | 2026-03-31 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2021-03-25 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2021-03-25 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2024-11-25 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2024-11-25 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2022-08-30 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-03-31 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2024-12-02 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2021-03-25 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2024-11-25 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2021-03-25 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2021-03-25 |
| System, Isokinetic Testing And Evaluation | IKK | Class 2 | Physical Medicine | No | 2021-11-29 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-09-27 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2023-09-27 |
Proprietary Names
IO Expandable Osteotomy Wedge System
CALLISTO 3DR PLIF
HYPERION 3DR TLIF
ANTARES 3DR ALIF
CALYPSO 3DR LLIF
EUROPA Pedicle Screw System
IO Expandable Lumbar Interbody
RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System
MiRus MoRe Lumbar Plating System
ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System
EUROPA Posterior Cervical Fusion Navigated Instruments
EUROPA Navigated Instruments
Cygnus MoRe Anterior Cervical Plate System
EUROPA Posterior Cervical Fusion System
MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation
CALYPSO PEEK LLIF
CALLISTO PEEK PLIF
HYPERION PEEK TLIF
ANTARES PEEK ALIF
RIGEL 3DR Cervical Interbody System
RIGEL 3DR Anterior Cervical Corpectomy System
Cygnus Anterior Cervical Plate System
Galileo Wrist Band
ATLAS MoRe Plating System
RIGEL Cervical Interbody System
Establishment Types
Manufacture Medical Device